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CSV Engineer

Job description

CSV Engineer

Looking to join a world leader in delivering Automation, MES and Digital Transformation solutions to Life Sciences. This is a full-time, permanent position based in Cork.

Job responsibilities:

  • Manage Computer System Validation projects from software install to business release
  • Generate computer system validation documentation in accordance with site procedures and GMP guidelines
  • Execute test scripts, analyse test results and determine the acceptability of results against pre-determined criteria
  • initiate and implement Change Control activities in accordance with Quality Standards and Practices
  • Determine solutions or recommendations for changes and/or process improvements

Job requirements:

  • Minimum 3-5 years’ experience validating IT applications e.g requirements gathering, design documentation, test case development, system & acceptance testing
  • Past proven experience engaging business users to ensure that appropriate business needs are clearly defined, communicated and delivered
  • Experience of server and workstation platform and working in a Win 10 environment
  • Experience of analysing and challenging s/w to identify gaps
  • Familiar with Annex 11/21CFR Part 11 requirements, GAMP 5 and data integrity guidelines

If you are interested in discussing this role, please reach out to Louise Whitty on 021 2359140 / lwhitty@sigmar.ie REF Z785954

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